From MDD and AIMDD to MDR

Useful information for a successful transition

Useful information for a successful transition

1. WHY YOU NEED TO TAKE ACTION NOW

While the date of application in May 2024 may seem far away at present, the time until then will be shortened by the following factors: 

  1. The efforts involved in transitioning to the new requirements are frequently underestimated. 
  2. Any MDD and AIMDD certificates still valid will expire on 26 May 2024 at the latest. While there were 58 Notified Bodies providing certification in accordance with the MDD and AIMDD in 2020 only 27 Notified Bodies are offering certification in accordance with the MDR at present. The German Medical Technology Association (BVMed) is warning of bottlenecks at Notified Bodies for this reason. 
  3. The transition of the already existing portfolio of devices (legacy devices) to the MDR requires significant additional input of resources on the part of manufacturers. To prevent internal resource constraints, experts recommend making an immediate start on the certification process in accordance with the MDR.

MDR transition timeline

To work with you on shaping the transition phase from the MDD and AIMDD to the MDR, we have assembled more in-depth information for you on this page.

 

  • 2. Helpful information to assist with the stricter MDR requirements applicable to your products

    Transition to the MDR can take longer than you may think. When transitioning from the AIMDD and MDD to the MDR, you should focus on the following aspects in particular: requirements for technical documentation, clinical data, biological safety, cybersecurity and consultation procedures.

     

    Technical documentation

    • Guidance for Submitting Technical Documentation to TÜV SÜD: Download here
    • White paper with comprehensive information about the aspects that need to be covered by your technical documentation: Download here
    • Short video about the general requirements for the technical documentation: Watch here
    • Short video providing fundamental information about the technical documentation: Watch here
    • Annex XVI to the MDR, devices not yet regulated: Read here
    • Article 117 of the MDR: Combination products: Read here

     

    Clinical data

    • Guideline on clinical data in “Guidance for Submitting Technical Documentation to TÜV SÜD”: Download here

     

    Biological safety     

    • Sterilisation practices made easy: Read here
    • Checklists for packaging, biocompatibility, reprocessing and sterilisation: Download here

     

    Cyber security

    • Guideline on cybersecurity in the “Guidance for Submitting Technical Documentation to TÜV SÜD”: Download here

     

    Consultation process

    • For some product categories, Notified Bodies must involve the Competent Authorities in the assessment procedure. NB: As this requires additional time, it is essential that you consider this aspect in your planning. Further information can be found at: Consultation Procedures for Medical Devices MDCG
  • 3. Fixed assessment dates for your technical documentation

    Important information regarding the assessment of technical documentations in accordance with the MDR: As of 1 June 2022, by prior appointment only

    From 1 June 2022 onwards, TÜV SÜD will only process technical documentations in accordance with the MDR if a date has been booked. Dates can be booked via your TÜV SÜD Account Manager from 1 April 2022.

    This supports reliable capacity planning on the part of both the company and the Notified Body. We consider this measure imperative in view of capacity constraints and, particularly, the expiring transition period for MDD and AIMDD certificates in May 2024.

    The number of available assessment dates depends on the capacity of the Notified Body. You are thus informed about our available resources and can make sure that TÜV SÜD is able to accept your planned assessment.

    How to book an assessment date

    To book an assessment date, you need to submit a complete pre-application or application. Please contact your TÜV SÜD Account Manager to request the required documents and book an assessment date.

    Your Account Manager will inform you about free capacities and assist you with booking your assessment date.

    By booking your assessment, you undertake to submit your technical documentation on the agreed date. If you fail to do so, we cannot ensure that the resources required for your assessment will be available and that no additional time and financial expenditures will be incurred.

    Conditions for booking and changing assessment dates

    If you are unable to keep the agreed assessment date, you have the possibility to defer your assessment once up to eight weeks before the scheduled submission date at the latest, subject to availability of other assessment dates. Any further changes of assessment dates will incur an additional fee. 

      Condition   Price
    Booking   Availability  Free of charge
    First change  

    Availability

    Up to 8 weeks before assessment date
     Free of charge
    Further changes  

    Availability

    Up to 8 weeks before assessment date
     Extra charge

  • 4. Documents required prior to assessment
    1. Framework agreement: Prerequisite for collaboration within the scope of the MDR. The framework agreement should be concluded now, irrespective of the time of assessment.
    2. MDR application documents: We need you to submit a complete application documentation for processing your order. This reduces processing time and ensures faster results.
    3. Technical documentation: Please use our “Guidance for Submitting Technical Documentation to TÜV SÜD” as a template for your complete file.

    Contact your TÜV SÜD Account Manager for the necessary documentation.

    New customer? Apply for registration here

  • 5. Next steps and contact

    Our specific recommendations:

     

    1. Review your portfolio now and identify the products for which you will be seeking certification in accordance with the MDR. 
    2. Assess your situation, taking into account that some of the requirements have become significantly stricter – particularly where clinical data are concerned. 
    3. Bring forward complex projects.
    4. Contact us and work with your TÜV SÜD Account Manager to draw up a schedule. 
    5. Book assessment dates to transition your products before May 2024. These appointments are limited!
    6. Download our “Guidance for Submitting Technical Documentation to TÜV SÜD” from our website. Follow the guidance strictly when compiling your files to ensure the documentation you submit is complete. 
    7. Submit your files as soon as they are completed. Do not wait until the scheduled submission date. This allows us to act faster on your behalf. 

    Please do not hesitate to contact your TÜV SÜD Account Manager if you have any questions regarding the transition to the MDR.

    New customers are kindly requested to apply for registration.

Next Steps

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